FDA approves Mitosol for use in glaucoma surgery

FDA has approved mitomycin (Mitosol, Mobius Therapeutics) for use in glaucoma surgery.

Mitosol provides a new system for delivering a precise dose of its active ingredient, mitomycin-c, for use in glaucoma procedures without any change to the surgeon’s current technique.

The approval of Mitosol for use in glaucoma surgery “will provide surgeons, hospitals, and patients with enhanced convenience, safety, and consistency in the surgical treatment of glaucoma," Ed Timm, president of Mobius Therapeutics, saisd in a company press release.

Glaucoma is the second-leading cause of blindness in the United States. It is treated progressively, beginning with pharmaceuticals, then office intervention, and finally surgery.

"The approval of Mitosol is an important event on multiple levels," Henry D. Jampel, MD, Odd Fellows and Rebekahs professor of ophthalmology at the Wilmer Eye Institute of Johns Hopkins University, said in a press release. "Surgeons, patients, and operating room staff will benefit from improved precision, convenience, quality assurance, and safety."

Mitosol is intended for topical application to the surgical site of glaucoma filtration surgery. It is not intended for intraocular administration.

Each vial of Mitosol contains 0.2 mg of mitomycin and mannitol in a 1:2 concentration ratio, according to the product’s package insert. To reconstitute, add 1 mL of sterile water for injection, then shake to dissolve. If product does not dissolve immediately, allow to stand at room temperature until the product dissolves into solution.

The most frequent adverse reactions to Mitosol occur locally and include hypotony, hypotony maculopathy, blebitis, endophthalmitis, vascular reactions, corneal reactions, and cataract.